Clinical trials are a necessary part of medical research and drug development. In fact, they are mandated by the Federal Drug and Safety Administration (FDA) as a necessary step along the path to FDA approval. The clinical trials are conducted to capture safety and efficacy data for health interventions including drugs, diagnostics, devices, and therapy protocols. Clinical trials can range from pilot studies with a small number of participants to very large studies with thousands of participants. Further, a single clinical trial can take place at one clinical site or may be spread across multiple clinical sites in different countries. Clinical trials are sponsored by the company seeking approval of the health intervention but may be managed by a contract research organization or a clinical trial unit in an academic center. These companies use clinical study auditors or monitors to provide oversight of the clinical study.
Ethical and regulatory guidelines surrounding human subject research in clinical trials require that clinical study monitors be given access to the medical records of clinical study participants to ensure that research documentation carried out at the clinical trial sites is an accurate and complete reflection of information actually documented in the participants' medical records. However, to maintain compliance with patient privacy standards set forth in the Health Insurance Portability and Accountability Act (HIPAA), clinical sites must ensure that clinical study monitors only access the medical records of patients who are actually participating in the clinical study, and the clinical sites must prevent access to medical records of patients who are not participating in the clinical study.
For clinical sites who utilize electronic medical record systems to store electronic medical records (EMRs) of patients, prior solutions to this problem have been both time and labor intensive. Solutions include printing the medical records of participants enrolled in a designated clinical study prior to an on-site visit by the clinical study monitor. This labor-intensive solution introduces a privacy risk in that the printed medical record must be appropriately controlled and destroyed after the visit.
Another solution requires the technical support staff at the clinical site to provide monitor-specific access to specified participants' electronic medical records for a specific time period. This must be done for each clinical study being conducted at the clinical site and must be done each time a monitor visits the site. This solution consumes valuable technical support resources. Yet another labor-intensive solution is to physically monitor access to participants' medical records by having a clinical site employee sit with the monitor as the monitor reviews a participant's electronic medical record. This helps to ensure that the monitor does not view other non-participant medical records.
There are also disadvantages to the current system from a clinical study monitor's perspective. For example, current solutions require that the monitor physically visit each clinical site which drives up the costs of research and development for the companies sponsoring the clinical trials. There is currently no safe or effective way for the clinical study monitor to remotely access the needed information.